2007 BUYER’S GUIDE

Overview of Endovenous
Thermal Ablation of
Varicose Veins
BY PETER GLOVICZKI, MD; ALESSANDRA PUGGIONI, MD; AND MANJU KALRA, MD

Endovenous interventions have trans-
formed the treatment of varicose veins
during the past decade. Interest in mini-
mally invasive endovenous thermal abla-
tion of the saphenous vein has substan-
tially increased due to multiple reasons.
Peter Gloviczki
Both radiofrequency ablation (RFA) and
endovenous laser therapy (EVLT) can be
performed as an office procedure; they
are less invasive and usually less painful
than conventional open surgical strip-
ping and appear to be equally as effec-
Alessandra tive. In addition, there is apparent benefit
Puggioni of earlier return to work and less tempo-
rary decrease in quality of life. Public
awareness of varicose veins and venous
disease has increased considerably, in
part because of activities of the
American Venous Forum and the
American College of Phlebology, but also
Manju Kalra because of increasing public advertise-
ment of minimally invasive techniques by the medical
industry. Informed patients seeking medical help for
Varicose Veins
In a recent issue of Endovascular Today, leaders of the
field expressed their opinion of currently used tech-
niques for varicose veins including RF, EVLT, endove-
nous chemical ablation with ultrasound-guided foam
sclerotherapy, as well as the conventional open sur-
gery of saphenous stripping and high ligation.1 This
article reviews currently used endovenous thermal
treatments for saphenous vein ablation in patients
with varicose veins and presents the most recent
results. We also provide an insight of what is on the
horizon from the medical industry to improve effica-
cy, expand indications, and decrease complications of
these procedures.
ENDOVENOUS THERMAL
ABLATION DEVICES
The principle of treatment using either RFA or EVLT is
to inflict direct endovenous thermal damage to the vein
wall resulting in destruction of the intima and collagen
denaturation of the media, with eventual fibrotic occlu-
sion of the vein. EVLT may also cause thermal damage
by indirect heating of the vein wall by generation of
intravascular steam bubbles in the venous blood. For

aching legs with unsightly veins or venous ulcers EVLT, laser wavelengths from 810 µm to 1,320 µm have
request RFA or EVLT for treatment of venous disease. been used with similar success (Table 1).
TABLE 1. ENDOVENOUS ABLATION DEVICES APPROVED FOR USE IN THE US

Device Name Manufacturer Wavelength (µm)

Laser
EVLT Diomed, Inc. (Andover, MA) 810
Venacure AngioDynamics, Inc. (Queensbury, NY) 810, 980
Medilas D Dornier MedTech (Kennesaw, GA) 940
VariLase Vascular Solutions, Inc. (Minneapolis, MN) 810
CTEV CoolTouch, Inc. (Roseville, CA) 1,320
Pro-V Sciton (Palo Alto, CA) 1,319

Radiofrequency
Closure VNUS Inc. (San Jose, CA) N/A

68 I ENDOVASCULAR TODAY I 2007 BUYER’S GUIDE

 2007 BUYER’S GUIDE

TABLE 2. KEY STEPS TO PERFORM ENDOVENOUS INDICATIONS

THERMAL ABLATION OF THE SAPHENOUS VEIN
• Use the micropuncture kit and needle to gain access
under ultrasound guidance into the saphenous vein
in the patient placed in the reversed Trendelenburg
position.
• Position tip of the catheter in the great saphenous
vein 1 cm distal to confluence of the superficial epi-
gastric vein.
• Use a single-dose, intraoperative, low-molecular-
weight heparin for DVT prophylaxis.
• Infiltrate tumescent anesthetic solution (50 mL 1% lido-
caine with and 1 mL epinephrine [1:1,000] diluted in 1 L
normal saline) into the saphenous subcompartment.
• Place the patient in the Trendelenburg position and
check position of the tip of the laser or RF device
with ultrasound immediately before treatment.
• Image the vein after treatment, re-treat if needed.
• Apply compression bandage from toes to groin with
selective padding over the treated saphenous vein to
optimize local compression.
• Ambulate immediately after surgery.
• Patients should take nonsteroidal anti-inflammatory
drug (ibuprofen, 400 mg three times daily po) for 5 days
after therapy to minimize aching and inflammation.
• Perform postoperative ultrasound within 24 to 72 hours.
EVLT and RFA are now widely accepted as minimally
invasive percutaneous endovenous techniques for abla-
tion of the great saphenous vein (GSV). They are also
used with increasing frequency to treat the small saphe-
nous vein (SSV), accessory saphenous veins, and the per-
forating veins. Indications for endovenous ablation are
identical to those for surgical high ligation and stripping:
reflux at the saphenofemoral or saphenopopliteal junc-
tion identified on duplex ultrasound in patients with vari-
cose veins or advanced chronic venous insufficiency,
including venous ulcers. It is prudent to avoid endovenous
thermal ablation in patients with large saphenous varices
or venous aneurysm located within 2 cm of the saphe-
nofemoral junction, or in patients who have the great
saphenous vein located immediately under the skin.
TECHNIQUE
Endovenous ablations can be performed as office
procedures under femoral block and/or local anesthesia,
with minimal discomfort and high patient satisfaction.
The patient is placed in the reversed Trendelenburg
position, and the target vein is accessed percutaneously
under ultrasound guidance at the knee (GSV) or ankle
level (SSV) using a micropuncture kit and needle (Table 2).
A guidewire is inserted into the vein followed by place-
ment of a 5-F sheath.2,3 The laser catheter or RF probe is
introduced through the sheath into the vein and

TABLE 3. RESULTS OF RFA AND EVLT

Investigator, Year Type of No. of Limbs Procedure Follow-Up Total Partial
Study (y) Occlusion (%) Occlusion (%)
Rautio,6 2001 RCT 33 RFA 1 75 26
Lurie,4,5 2003, 2005 RCT 44 RFA 2 89 7
Merchant,26 2002 CS 125 RFA 3 85 4
Pichot,27 2004 CS 65 RFA 2 90 10

Varicose Veins
Merchant,28 2005 CS 55 RFA 5 92
29
Nicolini, 2005 CS 330 RFA 3 75 17
Merchant,8 2005 CS 1,222 RFA 5 87 8
9
Min, 2003 CS 499 EVLT 2 93
Sadick,30 2004 CS 30 EVLT 2 97
Timperman,31 2005 CS 100 EVLT 1 91 4
Puggioni,3 2005 CS 53 RFA <1 94
Puggioni,3 2005 CS 77 EVLT <1 91
Kavuturu,32 2006 CS 66 EVLT 0.75 97 3
Myers,33 2006 CS 396 EVLT 3 80% (95% CI, 69%-87%)
Ravi,34 2006 CS 1,250 EVLT or RF 3 (143 limbs) 100% (GSV) 95% (SSV)
RCT = randomized controlled trial; CS=case series; RFA=radiofrequency ablation; EVLT=endovenous laser therapy; GSV=great saphenous vein; SSV=small saphenous vein.

2007 BUYER’S GUIDE I ENDOVASCULAR TODAY I 69

 2007 BUYER’S GUIDE
advanced proximally to the saphenofemoral or
saphenopopliteal junction. When treating the GSV, the
tip of the catheter is positioned 1 cm distal to the super-
ficial epigastric vein. For treatment of the SSV, the tip of
the probe is positioned 1 cm to 1.5 cm distal to the
saphenopopliteal junction. The patient is then placed in
the Trendelenburg position, and the vein is emptied by
elevation and by instillation of perivenous tumescent
anesthetic solution (50 mL 1% lidocaine with and 1 mL epi-
nephrine [1:1,000] diluted in 1 L normal saline) into the
saphenous subcompartment. The instilled fluid ensures
good contact of the vein wall with the treating catheter
for optimal therapeutic effectiveness; it also provides
analgesia and a heat sink around the treated vein there-
by decreasing heat-related injury to surrounding tissues
and reduces the risk of skin burns and paresthesias. The
vein is then ablated by withdrawing the catheter to a
few centimeters above the puncture site. The EVLT
catheter is withdrawn at a rate of 1 to 2 mm/s for the
first 10 cm and 2 to 3 mm/s for the remaining distance
to deliver 60 to 70 J/cm using 14 W continuous laser
energy. With RFA, the target temperature is either 85°C
or 90°C. When 85°C is used, the pullback rate is approxi-
mately 2 to 3 cm/min, and when 90°C is used, the pull-
back rate is commonly 4 cm/min. The pullback rate is less
for treatment of the 4-cm to 5-cm segment of the GSV
closest to the saphenofemoral junction. At the end of
the procedure, the saphenous vein is imaged with ultra-
sound to confirm occlusion and absence of thrombus in
the common femoral or popliteal veins. If a patent seg-
ment is identified, re-treatment is advisable. Direct com-
pression of the saphenous vein with pads under the
compression stocking or elastic bandage is advised. It is
important to get the patients ambulatory as soon as
possible. Data to support the routine administration of
thromboprophylaxis with heparin are not available.
Because we have observed extension of the saphenous
thrombus into the femoral vein, in our practice, a single
Varicose Veins
dose of low-molecular-weight heparin is used routine-
ly.2,3 If one prefers selective prophylaxis, it should be
used for patients with a history of thrombophlebitis,
deep vein thrombosis (DVT), obesity, or in patients
older than 50 years of age.3
RESULTS
Radiofrequency Ablation
The RFA system received Food and Drug Administration
(FDA) clearance in March of 1999. As of mid-2006, there
were more than 135,000 RFA procedures performed
worldwide. The Closure technique (VNUS Inc., San Jose,
CA) is well tolerated with minimal short- and long-term
morbidity. The clinical benefits of RFA have been demon-
strated through randomized clinical studies comparing
this technique with conventional vein stripping. The
70 I ENDOVASCULAR TODAY I 2007 BUYER’S GUIDE
EndoVenous Obliteration versus Ligation and Vein
Stripping (EVOLVeS), a company-sponsored prospective
randomized trial, demonstrated a 91% initial occlusion
rate with RFA and a complication rate that was similar in
both groups.4 The study found that postoperative pain
was significantly less severe, absence from work was short-
er, and physical function was restored faster after RFA than
stripping (Table 3). At 2 years, recurrent varicose veins
were noted in 14% of the RFA group versus 21% in the sur-
gical group, with statistically maintained better quality-of-
life scores in the RFA group.5 A prospective randomized
study by Rautio also showed less pain and more rapid
recovery after RFA versus stripping.6 Hinchliffe randomized
16 patients with recurrent GSV reflux to RFA and strip-
ping; RFA was faster, and the pain and bruising score was
less after RFA versus stripping.7 The Closure Study Group
studied more than 1,200 limbs;8 occlusion rates at 1, 2, and
5 years were 87.1%, 88.2%, and 87.2%, respectively (Table
3). Duplex ultrasound identified 185 limbs with anatomi-
cal failures, most (70%) due to recanalization of the
occluded saphenous vein; in 12%, the vein failed to
occlude initially and never occluded during follow-up,
whereas in 18%, the treated vein remained occluded, but
an accessory saphenous vein produced reflux.
Endovenous Laser Therapy
Large, single-center experiences with lasers have
achieved 97% to 98% early occlusion rates and have main-
tained occlusion in 93% of limbs at 3 years, with the
majority of recurrences occurring by the first 3 months.9-11
Min recently reported 98% occlusion up to 5 years after
laser treatment of 1,000 limbs.12 In an international registry
that included 5,262 patients, Kabnick et al reported a 96%
early success rate after GSV ablation with the 980-µm
laser.13 Navarro et al reported a 95% success rate with fol-
low-up extending to 4 years; recurrence was due to saphe-
nous recanalization and not neovascularization.14
The success of EVLT has been shown to depend on
the amount of energy delivered, with nonocclusion
and early reopening of the GSV seen more frequently
when <70 J/cm laser energy is used for saphenous vein
occlusion.15,16
A systematic review of EVLT was performed by Mundy
et al.17 None of the 13 studies analyzed had an open surgi-
cal control group. Occlusion of the GSV and abolition of
venous reflux occurred in 87.9% to 100% of limbs, with
low rates of re-treatment and recanalization. The study
concluded that EVLT benefits most patients in the short-
term, but rates of recanalization, re-treatment, occlusion,
and reflux may change with longer follow-up and that
there is a need for a randomized trial of EVLT versus con-
ventional surgery.
A recent study by Mekako et al18 compared early quali-
ty-of-life outcomes after EVLT and surgery between two
 2007 BUYER’S GUIDE
nonrandomized groups of patients. Seventy patients were
in the EVLT group and 62 were in the surgery group. The
quality-of-life scores were significantly better in the EVLT
group at 1 and 6 weeks, but not at 12 weeks. The investi-
gators concluded that EVLT removed the quality-of-life
limitations experienced by patients in the early postopera-
tive period.
COMPLICATIONS
Major complications after endovenous thermal ablation
of the saphenous veins are rare, but minor complications
have been reported in 3% to 20% of patients, including
bruising around the puncture site, bleeding, transient
paresthesias, superficial phlebitis, skin burns, or pigmenta-
tion. In the Closure Registry, paresthesia was observed in
12.3% (121 of 985 limbs) at 1 week, in 7.3% at 6 months,
and in 2.6% at 5 years.8 The incidence of skin burns and
paresthesias decreased to less than 1% with increasing
operator experience and with routine use of tumescent
anesthesia.8
Patients undergoing laser therapy frequently experience
a tight, pulling sensation in the medial thigh along the
course of the GSV, due to a mild-to-moderate form of
saphenous thrombophlebitis. Because blood is a chro-
mophore for all laser wavelengths used, any blood present
in the vein will predispose to thrombosis and throm-
bophlebitis.
Major complications of EVLT include DVT and pul-
monary embolism (PE). Although both DVT and PE are
rare, extension of thrombus from the saphenous into the
femoral or popliteal vein has been reported to occur in 0%
to 6% of the patients: in one study by Hingorani, extension
of thrombus occurred in 16% of the limbs after RFA.19
Kabnick recently introduced the term “endovenous heat-
induced thrombus” (EHIT).20 The natural history of EHIT is
likely more benign than that of a frank DVT; the registry of
Kabnick identified 16 observed cases with class 2 EHIT
(thrombus protruding into the femoral vein and occluding
Varicose Veins
up to 50% of the lumen). Currently, short-term (2 to 6
weeks) treatment with anticoagulation is recommended
to prevent thrombus progression or PE.
In 77 EVLT procedures, our group measured the median
distance between the tip of the saphenous vein thrombus
and the common femoral vein (CFV): the median distance
was 9.5 mm (range, -20 mm [protrusion in the CFV] to 50
mm), significantly less in older patients (r2=.12; P=.006).2
Thrombus protruded into the CFV in three limbs after
EVLT (2.3%).3,21 All three patients were treated with antico-
agulation; one underwent placement of a temporary infe-
rior vena cava filter because of a floating thrombus in the
CFV. Duplex scan at 12, 14, and 95 days, respectively,
showed complete resolution of the thrombus in all three
patients.
The rate of complications after EVLT in the International
72 I ENDOVASCULAR TODAY I 2007 BUYER’S GUIDE
Endovascular Working Group registry were recently
reported by Kabnick.20 In more than 7,000 limbs treated
with EVLT in 10 countries, the incidence of bruising was
75% (2,781 of 3,696), paresthesias occurred in 3% (114 of
3,696), thrombophlebitis occurred in 1.87% (69 of 3696),
skin burns occurred in 0.46% (17 of 3,696), DVT/EHIT
occurred in 0.27% (10 of 3,696), and PE occurred in 0.023%
(one of 3,696).20
Labrapoulos et al reported on early development of
arteriovenous fistulae in 4.9% of limbs undergoing RFA
treatment22; our group has observed the same after
EVLT. It is likely that arteriovenous fistulae develop dur-
ing the process of recanalization of the organized saphe-
nous thrombus, although heat injury to small arteries in
the vasa vasorum cannot be completely excluded. It is
very likely that arteriovenous neovascularization con-
tributes to recanalization or recurrence after endove-
nous ablation procedures.22 A rare but severe potential
complication of EVLT is a retained foreign body. This
complication is extremely rare, and the etiology is
unclear. A possible cause is if the probe (RF or laser) is
pulled back in the sheath and the tip of the sheath is
separated by direct heat.
INNOVATIONS
As a result of the lessons learned from initial experi-
ence, a number of changes have been introduced by
device manufacturers. The newest addition to the RF
catheter family, released in early 2006, was the VNUS
Closure RFS Stylet for ultrasound-guided ablation of per-
forating veins. The device has a thermocouple tempera-
ture feedback control to allow controlled, consistent
delivery of thermal energy to the vein wall. The tech-
nique is gaining popularity rapidly, and initial experience
has been satisfactory.
A second innovation from VNUS is the next genera-
tion of RFA systems, the ClosureFast catheter. Recently
cleared by the FDA, the ClosureFast catheter is expected
to be launched in the first quarter of 2007. This new
catheter eliminates the drawbacks of previous-genera-
tion catheters (slow pullback rates, pullback time to
measure, high impedance interruptions, normal saline
Figure 1. Key comparisons between ClosurePlus and
ClosureFast.
 2007 BUYER’S GUIDE
A B
Figure 2. New Diomed EVLT device (A) with Spotlight sheath (B) and multimedia card (C).
drip) and allows a shorter treatment time. Instead of the
traditional continuous pullback, this device operates
with a segmental ablation approach. The catheter is
composed of a 7-F–diameter heating element that has
no expanding electrodes so that one size fits all. The
catheter can be used with 8-F sheaths and is .025-inch
guidewire compatible; the device is available in 60-cm
and 100-cm lengths. The heating coil is 7 cm long and
the shaft marks are 6.5 cm apart, providing 0.5 cm treat-
ment overlap. The main difference between ClosureFast
and the old Closure system (or EVLT) is that the amount
of energy does not depend on the speed of pullback and
that a long vein segment is treated all at once. With this
device, a 7-cm segment (0.5 cm overlap) can be treated
in 20 seconds with set device temperature of 120ºC and
Varicose Veins
Figure 3. The CoolTouch automatic pullback device.
74 I ENDOVASCULAR TODAY I 2007 BUYER’S GUIDE
C
a vein wall temperature of 100ºC to 110ºC. The RF gen-
erator measures temperature continuously to adjust
power to the heating element; it detects when the
catheter is not in firm contact with the vein wall and the
computer advises to apply better compression. It is cru-
cial to collapse the vein around the catheter using eleva-
tion and perivenous tumescent solution infiltration
(Figure 1). Preliminary data provided by the manufactur-
er on 70 limbs demonstrate a 98% early occlusion rate
and a 100% reflux-free state after an average procedure
time of 21 minutes. No DVT, skin burn, or phlebitis
occurred, and 83% of limbs experienced no tenderness
postoperatively.
New from Diomed (Andover, MA) is the EVLT
Procedure Kit with the Spotlight Sheath and enhanced fea-
tures. The new Spotlight Sheath has an echogenic tip for
enhanced visibility under ultrasound, easy-to-confirm
location determination, and numbered sheath markings to
calculate length of segment treated. The Spotlight Sheath
is available in lengths of 45 cm and 70 cm. The sheath is
made with a new material that has enhanced lubricity and
stiffness to reduce the risk of kinking during insertion.
Further innovations in the new device are the fiber recog-
nition system and the multimedia card. The fiber recogni-
tion system allows the user to program the procedure pre-
sets and activate them upon starting the procedure, while
the multimedia card allows for storage of the digital data
from up to 100 treatments. The new EVLT laser generator
itself also appears more compact and lightweight for
portable office use (Figure 2).
The CoolTouch CTEV (CoolTouch, Inc., Roseville, CA) is a
1,320-µm Nd:YAG laser with an absorption length of 300 µm
to 500 µm in tissue. The device obtained FDA clearance for
treatment of both GSV and SSV. The chromophore for this
laser is water (main component of collagen), resulting in a
shorter absorption length than diode lasers. Specific
absorption of energy only by the vein wall and not the
hemoglobin results in a more controlled depth of vein
coagulation. Furthermore, the fiber is coupled with an
automatic pullback device preset at 1 mm/s. Other advan-
tages of this system are the availability of a number of fiber
sizes (600 mm, 273 mm, and the 2.5-F SaphFire
[CoolTouch]) and the disposability of the fibers; each can
 2007 BUYER’S GUIDE
be used up to five times after sterilization. The newly intro-
duced SaphFire 2.5-F fiber can be inserted through a small-
er and less-invasive 4-F microintroducer and, in many
instances, can be passed without the need for a sheath; it
travels a tortuous vein with relative ease due to the pro-
tected, smooth tip, it is more echogenic than other fibers,
and has excellent handling characteristics (Figure 3).
Potential advantages of 1,320-µm wavelength are efficacy
equal to the diode lasers with less damage to the surround-
ing tissues. Several investigators reported a significant
reduction of pain and bruising with the use of this wave-
length.23-25 A lack of vein wall perforations may account for
decreased laser damage of perivenous tissues and
decreased rate of side effects after 1,320-µm laser therapy.
CONCLUSION
The results of case series and registries on endovenous
thermal therapy of the incompetent saphenous veins in
patients with varicosity and advanced venous insufficien-
cy (some with follow-up data of 5 to 7 years) are reassur-
ing, with high occlusion rates, few side effects, and low
recurrence rates. Prospective randomized studies com-
paring RFA and stripping demonstrate earlier return to
work, less pain, and improved quality of life after endove-
nous procedures when compared to open surgery. No
randomized studies are currently available for EVLT. Strict
adherence to suggested guidelines and progress in tech-
nology will further decrease the low incidence of throm-
botic complication rates, perioperative pain, and pares-
thesias. Although these procedures are clearly less inva-
sive then conventional open surgery, level-1 evidence for
long-term superiority over other techniques used for
treatment of varicose veins is not available. ■
Peter Gloviczki, MD, is from the Division of Vascular
Surgery, Gonda Vascular Center, Mayo Clinic, Rochester,
Minnesota. He has disclosed that he holds no financial
interest in any product or manufacturer mentioned herein.
Varicose Veins
Dr. Gloviczki may be reached at (507) 284-3407;
gloviczki.peter@mayo.edu.
Alessandra Puggioni, MD, is from Maimonides Medical
Center, Brooklyn, New York. She has disclosed that she
holds no financial interest in any product or manufacturer
mentioned herein. Dr. Puggioni may be reached at (718)
283-7957; apuggioni@maimonidesmed.org.
Manju Kalra, MD, is from the Division of Vascular
Surgery, Gonda Vascular Center, Mayo Clinic, Rochester,
Minnesota She has disclosed that she holds no financial
interest in any product or manufacturer mentioned herein.
Dr. Kalra may be reached at (507) 284-3407;
kalra.manju@mayo.edu.
The authors acknowledge Brian Farley, President and
Chief Executive Officer VNUS Medical Technologies, Inc.
76 I ENDOVASCULAR TODAY I 2007 BUYER’S GUIDE
(San Jose, CA); Dan Stempel, Director, EVLT Marketing
Diomed, Inc., (Andover, MA); and Leslie Newman,
CoolTouch, Inc. (Roseville, CA).
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close veins: what is the reality behind the tool? Perspect Vasc Surg Endovasc Ther. 2006;18:3-8.
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the great saphenous vein: analysis of early efficacy and complications. J Vasc Surg. 2005;42:488-
493.
4. Lurie F, Creton D, Eklof B, et al. Prospective randomized study of endovenous radiofrequency
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1):174-178.
16. Timperman PE, Sichlau M, Ryu RK. Greater energy delivery improves treatment success of
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